BIO-CHECK GRAM STAIN CONTROL— 510(k) K821660

Name: FDA 510(k) clearance K821660
Creator: U.S. Food and Drug Administration
Published: 1982-06-25

Substantially Equivalent

American Scientific Products

FDA 510(k) clearance K821660 for BIO-CHECK GRAM STAIN CONTROL, Substantially Equivalent on 1982-06-25. Applicant: American Scientific Products. Device class: 1.

Clearance details

Applicant: American Scientific Products
Product code: Code JTR
Device class: Class 1
Regulation: 21 CFR 866.2480
Advisory panel: Microbiology
Date received: 1982-06-04
Decision date: 1982-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTR

view all

K871121 — PROTECT T.M.1987-04-14
K862914 — FEKAL CHECK PARASITOLOGY CONTROL SLIDE1986-09-16
K861022 — KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS1986-04-04
K855198 — INDI KWIK (TM) CO/TWO KIT1986-01-14
K842579 — B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS1984-07-27

More clearances from American Scientific Products

view all

K864824 — INFECTIOUS TISSUE KIT1986-12-24
K844042 — BLOOD DILUTION VIAL1984-10-23
K831634 — GLUCOSE REAGENT B6360-111983-07-19
K831625 — UREA NITROGEN-BUN-REAGENTS B6360-121983-07-07
K831626 — UREA NITROGEN-BUN-REAGENTS B6370-11A1983-07-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.